Dipatimenti Yapadziko Lonse

Pa 21 Marichi, 2025, Junshi Biosciences idalengeza kuti National Medical Products Administration ("NMPA") yavomereza kugwiritsa ntchito mankhwala atsopano ("sNDA") pa mankhwala a kampaniyo, toripalimab, pamodzi ndi bevacizumab pochiza matenda osachiritsika kapena ofalikira m'thupi.Werengani zambiri»

Pa Marichi 21, 2025, yalengeza kuti New Drug Application (“NDA”) ya TAVERIK® (tazemetostat) yavomerezedwa ku China kuti ichite chithandizo cha odwala akuluakulu omwe ali ndi matenda obwereranso kapena osagwirizana ndi mankhwala (“R/R”) follicular lymphoma (“FL”) omwe ali ndi kusintha kwa EZH2 omwe adalandira osachepera awiri ...Werengani zambiri»

Pa 10 Marichi, 2025, Sichuan Kelun-Biotech adalengeza kuti kampani ya trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yomwe kale inali SKB264/MK-2870) yavomerezedwa kuti igulitsidwe ndi National Medical Products Administration (NMPA...Werengani zambiri»

Pa 18 Marichi, 2025, Alphamab Oncology idalengeza kuti anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 yapatsidwa Breakthrough Therapy Designation ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA). Udindowu ndi wochizira ...Werengani zambiri»

Pa Marichi 10, 2025, Hansoh Pharma idalengeza kuti Pulogalamu Yatsopano yachitatu ("NDA") ya mankhwala atsopano a Gulu la Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) yavomerezedwa ndi National Medical Products Administration of China ("NMPA") kuti ichiritse odwala omwe ali ndi matenda amisala am'deralo,...Werengani zambiri»

Pa 12 Marichi, 2025, Zai Lab Limited idalengeza kuti bungwe la National Medical Products Administration (NMPA) la ku China lavomereza Fomu Yofunsira Chilolezo cha Biologics (BLA) ya TIVDAK (tisotumab vedotin-tftv) yochizira odwala omwe ali ndi khansa ya pachibelekero yomwe imabwereranso kapena yofalikira kwambiri yomwe matenda akupita patsogolo pa...Werengani zambiri»

Pa 5 Marichi, 2025, Ascentage Pharma idalengeza kuti mankhwala ake, olverembatinib, apatsidwa Breakthrough Therapy Designation (BTD) ndi Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA), chifukwa chophatikiza ndi chemotherapy yotsika mphamvu pa nthawi yoyamba ya chithandizo chamankhwala...Werengani zambiri»

Pa 4 Marichi, 2025, BeiGene idalengeza kuti US Food and Drug Administration (FDA) yavomereza TEVIMBRA (tislelizumab-jsgr), pamodzi ndi chemotherapy yokhala ndi platinum, kuti igwiritsidwe ntchito pochiza akuluakulu omwe ali ndi khansa ya squamous cell carcinoma (ESCC) yosachiritsika kapena yofalikira ...Werengani zambiri»

Pa 25 February, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza finotonlimab pamodzi ndi SCT510 pochiza khansa ya chiwindi yosachiritsika kapena yofalikira yomwe sinalandire chithandizo chamthupi. Finotonlimab ndi IgG4 yopangidwanso kuti ikhale yaumunthu...Werengani zambiri»

Pa February 8, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza finotonlimab ya Sinocelltech Group Ltd, yomwe ndi antibody ya programmed-death 1 (PD-1) monoclonal (mAb), kuti igwiritsidwe ntchito limodzi ndi chemotherapy yochokera ku platinum ngati chithandizo choyamba cha matenda obwerezabwereza komanso/kapena metastases...Werengani zambiri»

Pa February 21, 2025, Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA) yapereka Breakthrough Therapy Designation (BTD) ya Satri-cel (CT041) (mankhwala a autologous CAR T-cell omwe angagwiritsidwe ntchito motsutsana ndi Claudin18.2), kwa odwala omwe ali ndi vuto la m'mimba/m'mimba...Werengani zambiri»

Pa February 22, 2025, New Drug Application (NDA) ya jakisoni wa ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) yavomerezedwa ndi Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA) ndipo yapatsidwa Priority Review depth mu ...Werengani zambiri»